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BI 695501 Compared to Adalimumab in Patients With Active Rheumatoid Arthritis

NCT02137226 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 645

Last updated 2018-01-19

Study results available
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Summary

Primary Objective:

The primary objective of this trial is to establish an equivalence in efficacy between BI 695501 and US-licensed Humira® in patients with active Rheumatoid arthritis based on a statistical comparison of the proportion of patients meeting American College of Rheumatology 20% (ACR20) response rate at Week 12 and ACR20 response rate at Week 24 between BI 695501 and US-licensed Humira®.

Secondary Objectives:

The secondary objectives of this trial are to compare the efficacy, safety and immunogenicity of BI 695501 and US-licensed Humira® in patients with active RA including those undergoing the transition from US-licensed Humira® to BI 695501 after 24 weeks.

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

BI 695501

BI 695501, every two weeks for 48 weeks (25 injections in total)

DRUG

US-licensed Humira®

one injection every 2 weeks for 48 weeks (25 injections in total)

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-26
Primary Completion
2016-03-03
Completion
2016-10-18

Countries

  • United States
  • Bulgaria
  • Chile
  • Estonia
  • Germany
  • Hungary
  • Malaysia
  • New Zealand
  • Poland
  • Russia
  • Serbia
  • South Korea
  • Spain
  • Thailand
  • Ukraine

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02137226 on ClinicalTrials.gov